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Henlius and Organon Announce US FDA Approval of POHERDY® (pertuzumab-dpzb), the First PERJETA (pertuzumab) Biosimilar in the US
Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) today announced that the US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for POHERDY® (pertuzumab-dpzb) 420 mg/14 mL injection for intravenous use, an interchangeable biosimilar to PERJETA (pertuzumab), for all indications of the reference product.[1] POHERDY is the first and only approved pertuzumab biosimilar in the US, representing an important milestone in expanding access to quality
About this update from Shanghai Henlius Biotech, Inc. Class H
[{"type":"text","content":"SHANGHAI and JERSEY CITY, N.J., Nov. 17, 2025 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) today announced that the US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for POHERDY® (pertuzumab-dpzb) 420 mg/14 mL injection for intravenous use, an interchangeable biosimilar to PERJETA (pertuzumab), for all indications of the reference product.[1] POHERDY is the first and only approved pertuzumab biosimilar in the US, representing an important milestone in expanding access to quality and potentially more affordable biologic therapies for patients with certain HER2-positive breast cancers.[2]","length":676,"tagName":"p"},{"type":"text","content":""Expanding access to treatments for diseases that disproportionately impact women, including breast cancer, the most common cancer among women in the US excluding skin cancer, is at the core of our mission," said Jon Martin, US Commercial Lead, Biosimilars and Established Brands at Organon.[3] "Not only is POHERDY the first approved biosimilar to PERJETA in the US, but its approval also builds on Organon's recent momentum of expanding our biosimilars portfolio in women's health and oncology. Our collaboration with Henlius is critical to our goal of making health care more sustainable for US patients."","length":641,"tagName":"p"},{"type":"text","content":""The FDA approval of POHERDY marks a significant milestone in Henlius' global expansion and quality biologics development. As the first pertuzumab biosimilar approved in the US, this important achievement demonstrates our core capability to build a sustainable global R&D system grounded in rigorous scientific and regulatory standards. It also reflects Henlius' steadfast commitment to its patient-centric philosophy and long-term global strategy," said Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius. "We will continue accelerating the delivery of quality biologics to benefit more patients worldwide and create greater value for human health."[2]","length":717,"tagName":"p"},{"type":"text","content":""The approval of POHERDY further underscores Henlius' track record in international registration, together with our strength in quality management and com...